Senior Quality Assurance Supervisor

Reese Consumer Health; Cleveland (OH); On-site; USD 90,000 - 125,000; Full time

Job summary

Reese Consumer Health in Cleveland, OH is seeking a Senior Quality Assurance Supervisor to lead quality control and maintain the Quality Management System in a pharmaceutical manufacturing environment. You will train the quality team, manage CAPA workflows, review change controls, and partner with production to ensure cGMP compliance and product quality.

This role requires a Bachelor’s degree in a science or engineering field, 5+ years in QA/QC with cGMP, strong communication, and the ability to

Qualifications

• Bachelor’s degree in science, mathematics, engineering, or related field.
• 5+ years QA/QC with 5+ years cGMP in a pharmaceutical manufacturing environment.
• Familiarity with 21 CFR 210/211, 111, 820 desired.
• Strong leadership and communication skills.
• Proficient with Microsoft Office and quality systems.

Responsibilities

• Train and evaluate the quality team to meet quality objectives.
• Plan work and coordinate workflow balancing safety, quality and morale.
• Lead root cause analysis and CAPA for field complaints.
• Review and approve change controls and SOPs.
• Oversee cGMP aspects of production records and QA SOPs.
• Communicate quality issues and resolutions with operations management.

Skills

Leadership

Quality Assurance/Control

Regulatory knowledge (FDA CFR)

Communication skills

Training ability

Problem solving

Education

Bachelor's degree in science/engineering

Tools

Microsoft Office

Quality control software

Job description

Reese Consumer Health is a privately held manufacturer of OTC branded and private label products selling to national and regional chains, food and grocery stores, drug wholesalers, co-ops and independent pharmacies. Throughout the years, Reese Consumer Health has developed nationally recognized products.

Since our small beginning back in 1907, Reese Consumer Health has continued to grow and thrive and is now a 4th generation, family-run business. We supply the pharmaceutical industry, and ultimately, the consuming public, with high quality, unique medications that are stronger and more effective than either the name brands or their generic equivalents as well as equivalents to the name brands. We have expanded our production capabilities by adding more equipment to our facilities in order to keep up with our growing range of OTC and Healthcare products.

Position Summary:

Incorporating our company values: Accountability, Continuous Improvement, Customer Focus, Integrity, and Quality. As a member of quality management, maintain and improve the company Quality Management Systems. The Senior Quality Assurance Supervisor is responsible to lead quality control efforts and infrastructure in both Quality and Production.

JOB FUNCTIONS: (Job functions include but are not limited to the following)

• Train, motivate, and evaluate the quality team to meet the company’s quality objectives.
• Support the hiring and onboarding process in collaboration with department director.
• Plans work, makes assignments, and coordinates workflow to balance safety, quality, and moral standards to meet company objectives and customer expectations.
• Performs root cause analysis and CAPA follow up (if required) for complaints and inquiries received from the field.
• Evaluate training needs for quality personnel employee’s, perform on-the-job training / re-training, and evaluate the effectiveness of the training.
• Review and approve change controls applicable to manufacturing processes and procedures, analytical procedures, and related batch records/testing Standard Operating Procedures (SOPs); assures appropriate reports are issued, approved, and implemented.
• Oversee cGMP aspects of production records and develop quality and production SOP’s using the change control process, as identified through observation or the internal audit process.
• Communicate quality issues, trends and losses to operations management and identify appropriate resolutions with operations management assistance.
• Perform periodic review of SOP’s and internal audits according to applicable procedures.
• Other tasks as needed to support department and company goals and initiatives.

EDUCATION/ KNOWLEDGE/ SKILLS:

• Bachelor’s degree in science, Mathematics, Engineering or other related field required.
• Five or more years of experience in Quality Assurance / Quality Control, with a minimum of five years cGMP experience in a pharmaceutical manufacturing environment.
• Familiarity with 21 CFR part 210/211, part 111, and part 820 desired.
• Ability to lead and direct others.
• Microsoft office suite experience.
• Experience with regulatory authorities (i.e. FDA, FTC, EPA) and inspection preparation, execution, and response preferred.
• Knowledge of inspection and control methods, techniques and documentation.
• Excellent written and verbal communication skills.
• Strong computer skills, including ability to manage quality control applications
• Ability to travel as needed.

PHYSICAL DEMANDS:

• Frequently sitting or standing for extended periods of time up to 10-hours.
• Occasional bending, squatting, climbing, kneeling, and twisting required.
• Simple and power grasping with both right and left hands is required.
• Occasional Lifting up to 50 lbs.
• Reading computer screen or other electronic devices.
• Use of various office hand and electrical tools or equipment.

SCHEDULE DEMANDS:

General schedule is a 8-hours Monday – Friday 7:30 a.m. – 4:00 p.m. assignment, however, employee must be willing to work a flexible schedule including overtime and days that may include early mornings, and/or weekends and be punctual while doing so.

Reese Consumer Health is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, age, gender or sex (including pregnancy), national origin, ancestry, marital status, sexual orientation, gender identity, genetic identity, genetic information, disability, veteran/military status or any other basis prohibited by local, state, or federal law. Click here to view the Poster, EEO is the Law.